Integrated lc filters in catheter distal end

ABSTRACT

A distal-end assembly of a medical device, the distal-end assembly includes a flexible substrate and electrical conductors. The flexible substrate is configured to be coupled to a distal end of an insertion tube. The electrical conductors are disposed on the flexible substrate and are shaped to form: (i) one or more electrodes, configured to exchange electrical signals with a proximal end of the medical device, and (ii) one or more printed filters, which are disposed adjacently to at least one of the electrodes and are configured to filter signals in a predefined frequency range from the electrical signals exchanged between the at least one of the electrodes and the proximal end.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to a U.S. patent application entitled“Integrated resistive filters in catheter distal end,” Attorney DocketNo. BIO5855USNP filed on even date, whose disclosure is incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, andparticularly to filters integrated in catheter distal ends for cancelinginterference.

BACKGROUND OF THE INVENTION

In various medical procedures, a medical tool is inserted into a patientbody, which is simultaneously scanned using an anatomical imaging systemsuch as a magnetic resonance imaging (MRI) system. The medical tool maycomprise electrodes used to carry out the procedure. Various techniquesfor producing catheter electrodes operative in MRI environments areknown in the art.

For example, U.S. Patent Application Publication 2015/0366508 describesa flex-PCB catheter device that is configured to be inserted into a bodylumen. The flex-PCB catheter comprises an elongate shaft, an expandableassembly, a flexible printed circuit board (flex-PCB) substrate, aplurality of electronic components and a plurality of communicationpaths.

U.S. Patent Application Publication 2014/0024909 describes anMRI-compatible catheter that includes a shaft having opposite distal andproximal end portions. One or more RF tracking coils are positionedadjacent the distal end portion and each includes a conductive lead thatelectrically connects the RF tracking coil to an MRI scanner. Thecatheter includes one or more sensing electrodes at the shaft distal endportion, each electrically connected to a resistor having highimpedance.

SUMMARY OF THE INVENTION

An embodiment of the present invention that is described herein providesa distal-end assembly of a medical device, the distal-end assemblyincludes a flexible substrate and electrical conductors. The flexiblesubstrate is configured to be coupled to a distal end of an insertiontube. The electrical conductors are disposed on the flexible substrateand are shaped to form: (i) one or more electrodes, configured toexchange electrical signals with a proximal end of the medical device,and (ii) one or more printed filters shaped to form at least a resistor,which are disposed adjacently to at least one of the electrodes and areconfigured to filter signals in a predefined frequency range from theelectrical signals exchanged between the at least one of the electrodesand the proximal end.

In some embodiments, the predefined frequency range includes at leastpart of a radio frequency (RF) frequency range. In other embodiments,the signals filtered in the predefined frequency range are caused by amagnetic resonance imaging (MRI) system. In yet other embodiments, theflexible substrate includes a flexible printed circuit board (PCB).

In an embodiment, the flexible substrate is configured to wrap aroundthe distal end of the insertion tube. In another embodiment, one or moreof the printed filters are coupled to at least one of the electrodes. Inyet another embodiment, at least one of the printed filters isconfigured to pass electrical signals sensed, from tissue of a patient,by at least one of the electrodes.

In some embodiments, at least one of the printed filters is configuredto pass ablation signals to be applied to a patient tissue. In otherembodiments, the predefined frequency range includes 58 MHz-70 MHz.

In an embodiment, the one or more printed filters are made from one ormore materials selected from a list consisting of an alloy comprisingnickel and chromium, an alloy comprising copper and nickel, andtitanium. In another embodiment, at least one of the printed filters isconfigured to reduce one or more of: heating in the medical device,artifacts in an image acquired using the medical device, andinterference of the filtered signals with the electrical signalsexchanged between the at least one of the electrodes and the proximalend.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method for producing a distal-end assembly of amedical device, the method includes disposing on a flexible substrate,first electrical conductors shaped to form one or more electrodes forexchanging electrical signals with a proximal end of the medical device.One or more second electrical conductors are disposed adjacently to atleast one of the electrodes. The second electrical conductors are shapedto form one or more printed filters including at least a resistordesigned for filtering signals in a predefined frequency range from theelectrical signals exchanged between the at least one of the electrodesand the proximal end. The flexible substrate is coupled to a distal endof an insertion tube.

There is further provided, in accordance with an embodiment of thepresent invention, a distal-end assembly of a medical device, thedistal-end assembly includes a flexible substrate and electricalconductors. The flexible substrate is configured to be coupled to adistal end of an insertion tube. The electrical conductors are disposedon the flexible substrate and are shaped to form: (i) one or moreelectrodes, configured to exchange electrical signals with a proximalend of the medical device, and (ii) one or more printed filters, whichare disposed adjacently to at least one of the electrodes and areconfigured to filter signals in a predefined frequency range from theelectrical signals exchanged between the at least one of the electrodesand the proximal end.

In some embodiments, at least one of the printed filters is shaped toform at least one of an inductor and a capacitor. In other embodiments,the inductor and the capacitor are connected in parallel. In yet otherembodiments, the predefined frequency range includes at least part of aradio frequency (RF) frequency range.

In an embodiment, the signals filtered in the predefined frequency rangeare caused by a magnetic resonance imaging (MRI) system. In anotherembodiment, the flexible substrate includes a flexible printed circuitboard (PCB). In yet another embodiment, the flexible substrate isconfigured to wrap around the distal end of the insertion tube.

In some embodiments, one or more of the printed filters are coupled toat least one of the electrodes. In other embodiments, at least one ofthe printed filters is configured to pass ablation signals to be appliedto a patient tissue.

In an embodiment, the predefined frequency range includes 58 MHz-70 MHz.In another embodiment, at least one of the printed filters is configuredto reduce one or more of: heating in the medical device, artifacts in animage acquired using the medical device, and interference of thefiltered signals with the electrical signals exchanged between the atleast one of the electrodes and the proximal end.

There is additionally provided, in accordance with an embodiment of thepresent invention, a method for producing a distal-end assembly of amedical device, the method includes disposing on a flexible substrate,first electrical conductors shaped to form one or more electrodes forexchanging electrical signals with a proximal end of the medical device.One or more second electrical conductors are disposed adjacently to atleast one of the electrodes. The second electrical conductors are shapedto form one or more printed filters designed for filtering signals in apredefined frequency range from the electrical signals exchanged betweenthe at least one of the electrodes and the proximal end. The flexiblesubstrate is coupled to a distal end of an insertion tube.

The present invention will be more fully understood from the followingdetailed description of the embodiments thereof, taken together with thedrawings in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic, pictorial illustration of a catheterizationsystem, in accordance with an embodiment of the present invention;

FIG. 2 is a schematic, pictorial illustration of a flexible substratehaving electrodes and filters printed thereon, in accordance with anembodiment of the present invention;

FIGS. 3 and 4 are schematic, pictorial illustrations of filters formedin respective flexible substrates, in accordance with embodiments of thepresent invention;

FIG. 5 is a schematic, exploded pictorial illustration of a distal-endassembly of a catheter, in accordance with an embodiment of the presentinvention; and

FIG. 6 is a flow chart that schematically illustrates a method forproducing a catheter comprising electrodes and filters integrated on aflexible substrate, in accordance with an embodiment of the presentinvention.

DETAILED DESCRIPTION OF EMBODIMENTS Overview

Some medical procedures involve real-time anatomical imaging, carriedout, for example, using a magnetic resonance imaging (MRI) system.Medical devices that may be used simultaneously with the imagining, maycomprise catheters having electrodes used, for example, for conductingelectrical signals to or from patient tissue.

The MRI system applies a pulsed radiofrequency (RF) field to change theorientation of a magnetic field in tissue, resulting in induction of asignal at a specific frequency in an antenna (receiver coil). Thefrequency required to elicit a response from the tissue magnetization isdependent on the field strength of the externally applied magneticfield. For example, at a magnetic field of 1.5 tesla, the RF frequencyis about 64 MHz. Unless accounted for, the RF field of the MRI systemmay induce undesired RF signals in the catheter wiring and/orelectrodes, thereby distorting the desired signals of the catheter,creating image artifacts on the MRI scan, and undesirable heating alongthe catheter.

Embodiments of the present invention that are described hereinbelowprovide catheters adapted to operate in MRI environment. Specifically,the catheter comprises filters for canceling RF interference caused bythe MRI system, which interference may interfere with electrical signalsof the electrodes. Methods for producing catheters with integratedfilters are presented below as well.

In some embodiments, a catheter may comprise a distal-end assembly madefrom a flexible substrate, such as a flexible printed circuit board(PCB) sheet coupled to a distal end of an insertion tube.

In some embodiments, electrical traces are disposed on the PCB sheet insuitable patterns to form the electrodes, as well as filters that aredesigned to cancel interference caused to the electrodes due to theactivity of the MRI system.

The electrodes are configured to exchange electrical signals with aproximal end of the catheter, and the filters are formed adjacently tothe electrodes and are configured to filter out the RF signals thatinterfere with the exchanged electrical signals.

In some embodiments, the electrodes are configured to sense electricalsignals from a patient heart, in which case the filter comprises aresistor. In other embodiments, the electrodes are configured to applyablation signals to tissue of the patient heart, and the filtercomprises an inductor L and a capacitor C interconnected in parallel, inan LC circuit configuration.

In some embodiments, the electrodes and filters are produced using verylarge scale integration (VLSI) processes. In an embodiment, theelectrical traces are formed by depositing one or more conductive layerson an outer surface of the PCB sheet, for example by using one or morephysical vapor deposition (PVD) processes.

In an embodiment, the deposited conductive layers are shaped to form theelectrodes and filters using suitable patterning processes, such aslithography and etching. Subsequently, the distal-end assembly isproduced by wrapping the PCB sheet around the insertion tube.

The disclosed techniques help to improve the functionality of medicalcatheters to carry out complicated life-saving procedures, such aselectrophysiological (EP) mapping and tissue ablation, simultaneouslywith advanced imaging procedures such as MRI.

The disclosed techniques enable customizing the characteristics of thefilters integrated into the distal end of the catheter by formingsuitable circuits on the PCB sheet, e.g., using VLSI processes. Forexample, to filter out a first frequency range the filter may comprise asingle resistor, whereas to filter out a second frequency range thefilter may comprise a parallel LC circuit.

System Description

FIG. 1 is a schematic, pictorial illustration of a catheterizationsystem 20, in accordance with an embodiment of the present Invention.System 20 comprises a medical device, such as a probe, in the presentexample a cardiac catheter 22, and a control console 24. In theembodiment described herein, catheter 22 may be used for any suitabletherapeutic and/or diagnostic purposes, such as ablating tissue orsensing electrophysiological (EP) signals from a heart (not shown) of apatient 28.

In some embodiments, system 20 comprises a magnetic resonance imaging(MRI) system 38, which is configured to produce anatomical images ofpatient tissue. In some embodiments, MRI system 38 comprises magneticfield coils (not shown), comprising field gradient coils, which togethergenerate a spatially variant magnetic field.

The spatially variant magnetic field provides spatial localization forradio frequency (RF) signals generated in the system. In someembodiments, MRI system 38 produces RF signals at a frequency of about64 mega-hertz (MHz), or any other suitable range of RF frequencies.

In addition, MRI system 38 comprises transmitting and receiving coils(not shown). In a transmit mode the transmitting coils radiate RF pulsedenergy to patient 28, the RF pulses of energy interacting with thenuclear spins of the patient tissue and thereby realigning the magneticmoments of the nuclei away from their equilibrium positions. In areceive mode, the receiving coils detect RF signals received from thepatient's tissue as the tissue nuclei relax to their equilibrium state.

In some embodiments, console 24 comprises a processor 34, typically ageneral-purpose computer, with suitable front end and interface circuitsfor receiving signals from MRI system 38 and from catheter 22, and forcontrolling other components of system 20.

In some embodiments, console 24 further comprises a memory 50 and adisplay 46, which is configured to display data, such as an image 44 ofat least part of the heart of patient 28. In some embodiments, image 44may be acquired using MRI system 38, or using any other suitableanatomical imaging system.

A physician 30 (such as an interventional cardiologist) inserts catheter22 through the vascular system of patient 28 lying on a table 29.Catheter 22 comprises a distal-end assembly 40, shown in an inset 26 anddepicted in details in FIGS. 2 and 5 below. Physician 30 moves assembly40 in the vicinity of the target region in the heart by manipulatingcatheter 22 with a manipulator 32 near the proximal end of catheter 22.The proximal end of catheter 22 is connected to interface circuitry inprocessor 34.

In some embodiments, the position of distal-end assembly 40 in the heartcavity is typically measured using position sensing techniques. Thismethod of position sensing is implemented, for example, in the CARTO™system, produced by Biosense Webster Inc. (Irvine, Calif.) and isdescribed in detail in U.S. Pat. Nos. 5,391,199, 6,690,963, 6,484,118,6,239,724, 6,618,612 and 6,332,089, in PCT Patent Publication WO96/05768, and in U.S. Patent Application Publications 2002/0065455 A1,2003/0120150 A1 and 2004/0068178 A1, whose disclosures are allincorporated herein by reference.

In some embodiments, console 24 comprises a driver circuit 42, whichdrives magnetic field generators 36 placed at known positions externalto patient 28 lying on table 29, e.g., below the patient's torso.

Reference is now made to inset 26. In some embodiments, distal-endassembly 40 comprises a flexible printed circuit board (PCB) sheet 60,wrapped around an internal member 69 depicted in detail in FIG. 5 below.The internal member is also referred to herein as an insertion tube.

In some embodiments, assembly 40 further comprises a dome-cover 66,which is fabricated from a flexible PCB and configured to wrap around aring-shaped dome-support (shown in FIG. 5 below) using any suitablecoupling technique.

In some embodiments, PCB sheet 60 and/or dome-cover 66 may be perforatedso as to form one or more irrigation holes 64, which are configured toallow irrigation fluid to flow out from the insertion tube whenirrigating the tissue of the heart, for example during an ablationprocedure.

In some embodiments, assembly 40 further comprises one or moremicro-electrodes 62 and a ring electrode 80, which are configured toexchange electrical signals with the proximal end of catheter 22 and toconduct the electrical signals to or from the tissue of the heart.During a medical procedure, such as cardiac EP mapping or tissueablation, micro-electrodes 62 and ring electrode 80 are brought intocontact with the tissue of the heart, so as to sense electrical signalsoriginated therefrom, or to apply ablation signals for ablating thetissue as will be described below.

In the context of the present disclosure and in the claims, the terms“electrode” and “micro-electrode” are used interchangeably and refer tosensing electrodes or to ablating electrodes configured to senseelectrical signals from the heart or to ablate tissue of the heart,respectively.

In some embodiments, ring electrode 80 may be used for sensingelectrocardiogram (ECG) signals or any other type of signals from theheart of patient 28. Note that the description below mainly refers tomicro-electrodes 62, but is also applicable for ring electrode 80.

In some embodiments, micro-electrodes 62 are coated with a conductivelayer (made from, e.g., gold, or any other suitable material),configured to transfer the electrical signals to/from the tissue of theheart, at a predefined frequency range.

In some embodiments, assembly 40 may be used for ablating tissue of theheart. In some embodiments, during the ablation, micro-electrodes 62 areconfigured to transfer to the tissue electrical signals at a givenfrequency range.

In some embodiments, the conductive layer of micro-electrodes 62 istypically deposited on an outer surface of PCB sheet 60. In otherembodiments, the conductive layer may be deposited on dome-cover 66 inaddition to, or instead of on PCB sheet 60.

As described above, MRI system 38 produces RF signals, e.g., at apredefined frequency of 64 MHz, that may interfere with the electricalsignals exchanged between micro-electrodes 62 and the proximal end ofcatheter 22, cause image artifacts (e.g., in image 44), and undesirableheating along the catheter.

In some embodiments, one or more filters (shown in FIGS. 2-4 below) aredisposed (e.g., printed) on PCB sheet 60 adjacently to at least one ofmicro-electrodes 62. Typically, each electrode is associated with one ormore respective filters.

In an embodiment, the filters are configured to filter a predefinedfrequency range from interfering with the electrical signals exchangedbetween the respective micro-electrodes and the proximal end. In someembodiments, the frequency range may comprise a frequency of about 64MHz produced by MRI system 38 that has a magnetic field strength of 1.5tesla. An example method for producing distal-end assembly 40 andfurther details regarding the filters are depicted in details in FIGS.2-6 below.

In some embodiments, the filters and other components of the catheter,such as one or more thermocouples (not shown), may be produced betweenthe conductive layers of PCB sheet 60 or mounted on the outer surface ofPCB sheet 60. Thermocouples can be used for monitoring tissuetemperature during the ablation.

In some embodiments, processor 34 typically comprises a general-purposeprocessor, which is programmed in software to carry out the functionsdescribed herein. The software may be downloaded to the computer inelectronic form, over a network, for example, or it may, alternativelyor additionally, be provided and/or stored on non-transitory tangiblemedia, such as magnetic, optical, or electronic memory.

The configuration of distal-end assembly 40 shown in FIG. 1 is anexample configuration, which is chosen purely for the sake of conceptualclarity. In alternative embodiments, any other suitable configurationcan also be used. For example, the size and shape of distal-end assembly40, and the number and locations of micro-electrodes 62 and respectivefilters may be implemented using any suitable components and layoutappropriate for conducting a suitable medical procedure on tissue of anyorgan of patient 28. Furthermore, the flexible substrate used forimplementing the distal-end device may comprise any other suitablesubstrate other than a PCB.

Integrating Filters into the Catheter Distal End

FIG. 2 is a schematic, pictorial illustration of a flexible substrate48, in accordance with an embodiment of the present invention. In someembodiments, substrate 48 comprises a single section that may be usedfor producing a single unit of distal-end assembly 40. In otherembodiments, substrate 48 may comprise one or more substantially similarsections (not shown), used for producing multiple respective units ofdistal-end assembly 40.

In some embodiments, each section of substrate 48 comprises PCB sheet60, cover 66 and all other elements of assembly 40 depicted in FIG. 1above. These embodiments enable high-volume manufacturing (HVM) ofassemblies 40 by applying on substrate 48 one set of very large scaleintegration (VLSI) processes, described with reference to FIG. 1 above,for simultaneously producing multiple sections.

In some embodiments, the VLSI processes may comprise deposition of oneor more conductive layers at selected locations on an outer surface ofPCB sheet 60, using any suitable process, such as physical vapordeposition (PVD). The deposited conductive layers are shaped to formvarious components integrated on PCB sheet 60 and dome-cover 66, e.g.,using patterning processes, such as lithography and etching.

After concluding the production of the sections, substrate 48 is cut,such that each section is separated from its neighbor sections. In theexample of FIG. 2, substrate 48 comprises a single singulated section.

In some embodiments, PCB sheet 60 typically comprises electricalinterconnections, such as conductive traces 52, which are configured toelectrically connect the electronic devices coupled to substrate 48 tosuitable wires that traverse the catheter, and to electrically connectbetween the proximal end of catheter 22 and electrodes 62.

In some embodiments, one or more filters 70 are printed on PCB sheet 60,adjacently to respective micro-electrodes 62. In some embodiments,filters 70 are configured to filter out interfering signals in apredefined frequency range (e.g., 58 MHz-70 MHz). In an embodiment,filter 70 may comprise an inductor L and a capacitor C interconnected inparallel, in an LC circuit configuration shown in detail in FIG. 3below. In this embodiment, the LC circuit may serve as a band-stopfilter of high impedance signals centered around 64 MHz.

In other embodiments filters 70 uniformly attenuate interfering signalsacross essentially the entire useful frequency range. In an embodiment,filter 70 may comprise a resistor R coupled to electrode 62 and to trace52. In this embodiment, resistor R is configured to attenuate currentsof all frequencies but low currents, such as pico-ampere (pA) currents,conducted on trace 52. The reduction of high currents reduces imageartifacts on the MRI scan (e.g., on image 44), and undesirable heatingalong catheter 22.

The interfering signals are produced by MRI system 38 and are filteredout so as to reduce or even cancel interferences they may cause to theelectrical signals exchanged between micro-electrodes 62 and theproximal end of catheter 22.

Note that the interfering signals, from MRI system 38 or from any othersource, may interfere with the intended operation of various componentsof system 20 and are typically conducted from the blood or tissue tomicro-electrodes 62 and into the catheter by traces 52.

In some embodiments, each filter 70 is physically coupled tomicro-electrode 62, such that filter 70 is configured to block orsufficiently attenuate any interfering signal in a predefined frequencyrange (e.g., 58 MHz-70 MHz) that would otherwise be conducted betweenmicro-electrodes 62 and the proximal end of catheter 22, via traces 52.

In some embodiments, a filter 82 is printed on PCB sheet 60, adjacentlyto ring electrodes 80. Filter 82 is configured to filter out interferingsignals in a predefined frequency range (e.g., 58 MHz-70 MHz) so as toreduce the level of noise from the ECG signals sensed by ring electrode80. In some embodiments, filter 82 may have a structure similar tofilter 70 of micro-electrodes 62. In alternative embodiments, filter 82may have any other suitable structure.

In principle it is possible to block the interfering signals byimplementing filters of a predefined frequency range at the proximal endof catheter 22, e.g., at manipulator 32. However, this configurationdoes not eliminate the heating induced on the wires that span the lengthof the catheter nor does it address the associated image artifacts.Therefore, the desirable location for disposing the filters so as toblock the interfering signals is as close to the respective electrodes(e.g., electrodes 62 and 80) of distal-end assembly 40 as possible.

In some embodiments, micro-electrodes 62 may be used for sensinglow-voltage electrical signals from the heart of patient 28, e.g., onthe order of 0.01 mV-1 mV. In these embodiments, a first type of filter70 is suitable for filtering the interfering signals from MRI system 38.In other embodiments, the electrodes are configured to apply ablation,e.g., to the heart tissue, using high-current electrical signals, suchas 50 mA-5 A.

In these embodiments, a second type of filter 70, different from thefirst type is suitable for filtering the interfering signals.Embodiments that employ the first and second types of filters aredepicted in detail in FIGS. 3-4 below.

In alternative embodiments, electrodes 62 may conduct any other type ofelectrical signals to/from any organ of patient 28, in the presence ofinterfering signals of any frequency-range.

In these embodiments, system 20 may require, for each type of electricalsignal, a different type of filter, suitable for blocking interferingsignals having a respective frequency-range.

In an embodiment, irrigation holes 64 are formed in sheet 60 and/or ondome-cover 66, when sheet 60 and cover 66 are in a planar position,before wrapping around member 69 and the ring-shaped dome-support asshown in FIG. 5 below.

In some embodiments, sheet 60 comprises a section 54, which isconfigured to connect the edges of sheet 60 to one another, when sheet60 is wrapped around member 69, and to connect between PCB sheet 60 andcover 66, as will be described in FIG. 5 below.

In some embodiments, cover 66 comprises multiple tabs 51, each of whichis extended from a respective section 53 of cover 66, and are configuredto couple between dome-cover 66 and section 54 of sheet 60.

In some embodiments, section 54 and some of tabs 51 comprise exclusionzone elements 57, which are created in some of tabs 51 so as to notoverlap irrigation holes 64 when sheet 60 and cover 66 are in a wrappedposition around member 69.

In alternative embodiments, after wrapping, the left and right edges ofsheet 60 may be coupled to one another by welding, adhesive, or usingany other suitable technique to couple sheet 60 and cover 66 to member69, and to one another.

In some embodiments, sheet 60 and cover 66 of section 48 are shown in aplanar form after concluding the VLSI processes, and before wrappingsheet 60 and cover 66 around member 69 and on the apex of assembly 40,respectively, as will be depicted in detail in FIG. 5 below.

FIG. 3 is a schematic, pictorial illustration of filters 72 and ablationelectrodes 63 formed on PCB sheet 60, in accordance with an embodimentof the present invention. Filters 72 and ablation electrodes 63 mayrespectively replace, for example, filters 70 and electrodes 62 of FIG.2 above.

In other embodiments, electrodes 63 and filters 72 may be formed incover 66, in addition to, or instead of being formed on PCB sheet 60.

The process depicted hereinbelow is suitable for producing electrodes 63and filters 72 in sheet 60 and/or in cover 66.

In some embodiments, electrodes 63 are delivering currents andconfigured to conduct ablation signals from the proximal end of catheter22 to the heart tissue of patient 28. In some embodiments, filters 72are configured to pass ablation signals, e.g., from the proximal end ofcatheter 22, to electrodes 63 for ablating the patient tissue.

In an embodiment, filter 72 comprises a parallel LC circuit comprisingan inductor L and a capacitor C connected in parallel. In the example ofFIG. 3, one terminal of filter 72 is coupled to trace 52 and the otherterminal of the filter is coupled to electrode 63, similar to theinterconnection configuration of filter 70 in FIG. 2 above.

In some embodiments, inductor L and capacitor C are made from one ormore conductive layers of electrical traces of preferably gold or copperdeposited on PCB sheet 60 using a PVD process or any other suitableprocess. The conductive layers are deposited in a suitable shape to formthe components comprising filter 72, e.g., using lithography and etchingprocesses.

In some embodiments, inductor L and capacitor C of filter 72 may bepatterned using a single mask configured to pattern other components ofPCB sheet 60, such as traces 52 and electrodes 63.

In other embodiments, filter 72 may be formed using any other suitablesequence of deposition and patterning processes, such as using separatelithography mask and patterning process.

In some embodiments, filter 72 is configured to filter signals in apredefined frequency range from being coupled onto trace 52 causingcatheter heating and image artifacts. In these embodiments, thefrequency of the interfering signals comprises the 64 MHz frequencyproduced by 1.5T MRI system 38. In the case of a different magneticfield strength the corresponding Larmor frequency would be used.

In some embodiments, the configuration of filter 72 is suitable forfiltering signals from interfering with the ablation signals havingtypical currents values of 50 mA to 5 A and frequency range of 50 kHz to25 MHz.

Note that small values of inductance (e.g. 1 nH to 1000 nH) andcapacitance (e.g., 5 pF to 5000 pF) are sufficient for inductor L andcapacitor C of filter 72 to attenuate the interfering signals from MRIsystem 38.

In other embodiments, any other suitable configuration of one or moreinductors L, and/or capacitors C, and/or other components, may bearranged to form a filter compatible with any type of electrode formedon substrate 48. Furthermore, each component of filter 72 (e.g.,capacitor C) may have any suitable value.

FIG. 4 is a schematic, pictorial illustration of filters 74 andmicro-electrodes 65 formed in PCB sheet 60, in accordance with anembodiment of the present invention.

Filters 74 and micro-electrodes 65 may respectively replace, forexample, filters 70 and micro-electrodes 62 of FIG. 2 above. In someembodiments, filter 74 comprises a resistor R coupled to electrode 65and to trace 52.

In some embodiments, micro-electrodes 65 are non-current carryingelectrodes configured to sense electrical signals from the tissue of theheart of patient 28. In the example of system 20, the electrical signalssensed by micro-electrodes 65 have a current range of 1 pA-1 pA, and afrequency range of 0.01-1000 Hz.

In some embodiments, filter 74 is configured to filter a predefinedfrequency range from interfering with the electrical signals of theheart tissue that are sensed by micro-electrodes 65. In someembodiments, filter 74 is further configured to pass the electricalsignals of the heart tissue that are sensed by micro-electrodes 65 andconducted, via traces 52, to processor 34.

Note that each filter 74 is formed with close proximity (e.g., a fewmillimeters or even physically coupled) to a respective micro-electrode65 so as to filter the aforementioned interfering signals. Theinterfering signals may be produced by MRI system 38 or by any othersource.

In some embodiments, resistor R is formed by patterning a suitableresistive layer between trace 52 and micro-electrode 65. For example,resistor R may be formed by shaping the width of a section of trace 52to be narrowed in proximity to micro-electrode 65. In thisconfiguration, the section of trace 52 having a thinner width may havehigher a resistance compared to the other sections of traces 52, therebymay attenuate or completely block the interfering signals frominterfering with the heart signals sensed by micro-electrode 65.

In other embodiments, resistor R may be made from a material other thanthe material from which traces 52 are made, having a higher inherentresistance compared to the material of traces 52, such as nichrome (analloy comprising nickel and chromium), constantan (an alloy comprisingcopper and nickel), titanium, or any other suitable material.

In other embodiments, resistor R may be made by either depositing lessconductive material to make a feature which has lower thickness ofmaterial thickness, or by selectively removing material leaving athinner layer of material behind.

In other embodiments, any suitable combination of the techniquesdescribed above may be applied so as to provide the desired resistanceof resistor R. For example, a narrow and thin feature may be formed outof a material having higher inherent resistance.

The configuration of filters 72 and 74 shown in FIGS. 3 and 4 above aredepicted purely by way of example. In alternative embodiments, substrate48 of distal-end assembly 40 may comprise any other types andconfigurations of filters suitable for filtering any predefinedfrequency range of interfering signals. The characteristics of suchfilters are defined by the types and arrangements of such components(e.g., combinations of RLC or RC circuits) and the characteristics ofeach component of the filter.

FIG. 5 is a schematic, exploded pictorial illustration of distal-endassembly 40, in accordance with an embodiment of the present invention.FIG. 5 shows the opposite surfaces of sheet 60 and cover 66 from thoseshown in FIG. 2 above.

In some embodiments, internal member 69 of distal-end assembly 40 may bemade of plastic or any other suitable material. Member 69 may have askeleton support structure, as shown in FIG. 5, or any other suitablestructure.

A base 58 is located at the proximal end of member 69, a ring-shapeddome-support 68 is located at the apex of member 69, and multiple ribs56 connect the base and the dome-support. In this embodiment, member 69has an internal lumen for directing irrigation into the inside of cavityformed by flexible PCB sheet 60.

In some embodiments, dome-cover 66 may be glued to dome-support 68, orcoupled thereto using the configuration depicted in FIG. 2 above. Inalternative embodiments, cover 66 may be fabricated from a liquidcrystal polymer (LCP) PCB, which may be formed (e.g., thermoformed) intoa cup shape and bonded to sheet 60. The cup shape may be bonded todome-support 68 and sheet 60 bonded to base 58 using any suitablebonding technique known in the art.

In some embodiments, sheet 60 and cover 66 are made from a single pieceof contiguous PCB or any other suitable flexible substrate. Inalternative embodiments, sheet 60 and cover 66 may be formed fromseparate pieces of material and coupled to one another using welding orany other suitable coupling technique.

FIG. 6 is a flow chart that schematically illustrates a method forproducing distal-end assembly 40, in accordance with an embodiment ofthe present invention. The method begins with depositing a firstconductive layer on first selected locations of flexible substrate 48,at a first deposition step 100.

At a second deposition step 102, a second conductive layer is depositedon flexible substrate 48 at second selected locations that are adjacentto the first selected locations. In some embodiments, the first andsecond conductive layers are made from the same material, such as goldor any other suitable material.

In these embodiments, the first and second conductive layers may bedeposited simultaneously, so that steps 100 and 102 are carried out as asingle deposition step. In other embodiments, the first and secondconductive layers are made from different respective materials and aretypically deposited at different process steps.

In some embodiments, the first conductive layer is deposited across theentire surface of substrate 48, and subsequently patterned so as toretain only parts of the first conductive layer on the first selectedlocations of flexible substrate 48. Likewise, the second conductivelayer may be deposited across the entire surface of substrate 48, andsubsequently patterned so as to retain only parts of the secondconductive layer on the second selected locations of flexible substrate48.

After concluding step 102, the first and second conductive layers aredeposited adjacent to one another, typically, in a physical contact withone another.

At a patterning step 104, the first conductive layer is shaped so as toform electrodes, such as micro-electrodes 62, and the second conductivelayer is shaped so as to form filters, such as filters 70. In anembodiment, the shaping of the first and second conductive layers iscarried out using a single patterning process.

In this embodiment, the patterning process may comprise using a singlemask that defines the shapes of micro-electrodes 62 and filters 70,followed by one or more etching steps configured to transfer the shapesdefined by the mask.

In alternative embodiments, the process sequence described in steps 100,102 and 104 may comprise depositing the first conductive layer andpatterning the shape of micro-electrodes 62 using a first mask, andsubsequently depositing the second conductive layer and patterning theshape of filters 70 using a second mask.

The description of the processes in steps 100, 102, and 104 above issimplified for the sake of clarity, and these example steps are depictedpurely by way of example. In alternative embodiments, any other suitableprocess may be used to produce micro-electrodes 62 and filters 70adjacent to, or coupled to one another.

In some embodiments, at least one of the first and second conductivelayers may comprise a multilayered structure, each conductive layer madefrom at least two types of sublayers.

At a tip formation step 106, substrate 48 is coupled to member 69 usingone of the techniques depicted in FIGS. 2 and 5 above. In the example ofdistal-end assembly 40, flexible PCB sheet 60 is wrapped around base 58and ribs 56, and dome-cover 66 is wrapped around dome-support 68. Insome embodiments, step 106 concludes the method and enables theformation of distal-end assembly 40.

Although the embodiments described herein mainly address mapping andtreatment of cardiac arrhythmias, the methods and systems describedherein can also be used in other applications, such as in otolaryngologyor neurology procedures.

It will thus be appreciated that the embodiments described above arecited by way of example, and that the present invention is not limitedto what has been particularly shown and described hereinabove. Rather,the scope of the present invention includes both combinations andsub-combinations of the various features described hereinabove, as wellas variations and modifications thereof which would occur to personsskilled in the art upon reading the foregoing description and which arenot disclosed in the prior art. Documents incorporated by reference inthe present patent application are to be considered an integral part ofthe application except that to the extent any terms are defined in theseincorporated documents in a manner that conflicts with the definitionsmade explicitly or implicitly in the present specification, only thedefinitions in the present specification should be considered.

1.-22. (canceled)
 23. A distal-end assembly of a medical device, thedistal-end assembly comprising: (a) a flexible substrate, the flexiblesubstrate being configured to be coupled to a distal end of an insertiontube, the flexible substrate including: (i) a flexible printed circuitboard sheet configured to wrap around the insertion tube, the flexibleprinted circuit board sheet being bendable to define a circumferentiallyextending region encompassing a circumference of the insertion tube,(ii) a dome-cover configured to wrap around a dome-support, and (iii)one or more tabs extending from the dome-cover and configured to couplethe dome-cover with the flexible printed circuit board sheet; and (b)one or more electrodes, the one or more electrodes being disposed on oneor both of the dome cover or the circumferentially extending region ofthe flexible printed circuit board.
 24. The distal-end assembly of claim23, the one or more electrodes being configured to exchange electricalsignals with a proximal end of the medical device.
 25. The distal-endassembly of claim 23, further comprising electrical conductors on theflexible substrate, the electrical conductors being shaped to form oneor more printed filters.
 26. The distal-end assembly of claim 25, atleast one of the one or more printed filters being configured to filtersignals in a predefined frequency range from electrical signalsexchanged between at least one of the one or more electrodes and theproximal end, the predefined frequency range comprising at least part ofa radio frequency (RF) frequency range.
 27. The distal-end assembly ofclaim 25, at least one of the one or more printed filters being shapedto form at least one of an inductor or a capacitor.
 28. The distal-endassembly of claim 25, at least one of the one or more printed filtersbeing configured to pass ablation signals to be applied to a patienttissue.
 29. The distal-end assembly of claim 23, the dome-coverextending distally from a distal edge region of the flexible printedcircuit board sheet.
 30. The distal-end assembly of claim 23, the domesupport being ring-shaped.
 31. The distal-end assembly of claim 23, oneor both of the flexible printed circuit board sheet or the dome-coverdefining a plurality of irrigation openings.
 32. The distal-end assemblyof claim 23, further comprising a cardiac catheter, the insertion tubebeing defined by a distal portion of the cardiac catheter, the flexiblesubstrate and the one or more electrodes being positioned at the distalportion of the cardiac catheter.
 33. A method for producing a distal-endassembly of a medical device, the method comprising: (a) disposingelectrical conductors on a flexible substrate, the flexible substratecomprising: (i) a flexible printed circuit board sheet, (ii) adome-cover, and (iii) one or more tabs configured to couple the flexiblesubstrate with the dome-cover, the disposed electrical conductorsforming one or more electrodes, the one or more electrodes beingdisposed on one or both of the dome cover or the flexible printedcircuit board; (b) coupling the flexible substrate to a distal end of aninsertion tube, the act of coupling the flexible substrate to the distalend of the insertion tube including wrapping the flexible printedcircuit board sheet around the insertion tube; and (c) wrapping thedome-cover around a dome-support.
 34. The method of claim 33, at leastone of the one or more electrodes extending circumferentially about theinsertion tube after the flexible substrate is coupled to the distal endof the insertion tube.
 35. The method of claim 33, further comprisingforming a plurality of irrigation openings through one or both of theflexible printed circuit board sheet or the dome-cover.
 36. The methodof claim 33, further comprising disposing one or more additionalelectrical conductors on the flexible substrate, the one or moreadditional electrical conductors being shaped to form one or morefilters configured to filter signals in a predefined frequency rangefrom electrical signals exchanged between the at least one of theelectrodes and a proximal end of the medical device.
 37. The method ofclaim 36, further comprising shaping the one or more filters to form aninductor and a capacitor
 38. The method of claim 37, further comprisingconnecting the inductor and the capacitor in parallel.
 39. The method ofclaim 33, the act of wrapping the come-cover around a dome-supportcomprising deforming the one or more tabs.
 40. The method of claim 33,the act of coupling the flexible substrate to the distal end of theinsertion tube further including securing a first longitudinallyextending end of the flexible substrate to a second longitudinallyextending end of the flexible substrate along a length of the insertiontube.
 41. An apparatus, comprising: (a) a cardiac catheter, the cardiaccatheter having a distal portion including: (i) a tubular structure, and(ii) a dome-support structure distal to the tubular structure; and (b) adistal-end assembly secured to the distal portion of the cardiaccatheter, the distal-end assembly including: (i) a flexible printedcircuit board sheet wrapped around the tubular structure, (ii) adome-cover wrapped around the dome-support structure, (iii) one or moretabs extending from the dome-cover, the one or more tabs coupling thedome-cover with the flexible printed circuit board, and (iv) a pluralityof electrodes, the electrodes being disposed on one or both of theflexible printed circuit board sheet or the dome-cover.
 42. Theapparatus of claim 41, the distal-end assembly further including aplurality of filters printed on the flexible printed circuit boardsheet, the filters being configured to filter electrical signals to orfrom the electrodes.